Status:

COMPLETED

Methotrexate (Rheumatrex) High Dose Special Investigation (Regulatory Post Marketing Commitment Plan)

Lead Sponsor:

Pfizer

Conditions:

Arthritis

Rheumatoid

Eligibility:

All Genders

17-99 years

Brief Summary

This Investigation is to be performed for the purpose of assessing the following information in the long-term post-marketing daily medical practice in the patients who receive REUMATOLEX 2 mg Capsule ...

Detailed Description

Implemented as a Special Investigation by Central Registration System

Eligibility Criteria

Inclusion

  • Patients need to be administered Rheumatrex in order to be enrolled in the survey
  • Patients who receive the Rheumatrex at the dose higher than 8 mg/week for the treatment of Rheumatoid Arthritis

Exclusion

  • Patients who have been treated with Rheumatrex at the dose higher than 8 mg/week since the days when the high dose therapy for RA was not approved
  • Patients who have been treated MTX other than Rheumatrex administered Rheumatrex

Key Trial Info

Start Date :

May 1 2011

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 1 2014

Estimated Enrollment :

2860 Patients enrolled

Trial Details

Trial ID

NCT01414257

Start Date

May 1 2011

End Date

March 1 2014

Last Update

August 6 2018

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of Occupational and Environmental Health Hospital

Kitakyushu-shi, Fukuoka, Japan